Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT01490333
Eligibility Criteria:
Inclusion Criteria:
* Ambulatory, community dwelling AI woman
* Postmenopausal up to age 75 years; for women below age 55, postmenopausal status must be confirmed by documentation of serum FSH\>30 IU/L and estradiol \< 20 pg/ml unless a bilateral oophorectomy is documented.
Exclusion Criteria:
* Serum 25(OH)D \< 10 or \> 60 ng/ml.
* Known CVD (history of MI, coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, peripheral arterial disease with claudication).
* Uncontrolled thyroid disease (thyroid stimulating hormone level outside of normal range).
* Change in dose of lipid lowering medications within the preceding six weeks.
* Mastectomy of the right breast
* Non-English speaking, illiterate, impaired decision making.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT01490333
Study Brief:
Protocol Section:
NCT01490333